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NCT03236207
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
NA trial testing Test extensively hydrolyzed formula in Cow Milk Allergy in 67 participants. Completed in 6 November 2018.
6 November 2018
Quick facts
| Lead sponsor | Société des Produits Nestlé (SPN) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 6 July 2017 |
| Primary completion | 6 November 2018 |
| Estimated completion | 6 November 2018 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- Test extensively hydrolyzed formula
- Control extensively hydrolyzed formula
Conditions studied
- Cow Milk Allergy — all drugs for Cow Milk Allergy →
Sponsor
Société des Produits Nestlé (SPN) — full company profile →
Who can join
Adults 2 Months to 4, any sex, with Cow Milk Allergy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Confirmed Hypoallergenicity of a Novel Whey-Based Extensively Hydrolyzed Infant Formula Containing Two Human Milk Oligosaccharides.
Nowak-Wegrzyn A, Czerkies L, Reyes K, Collins B, et al · · 2019 · cited 31× · PMID 31248026 · DOI 10.3390/nu11071447
Verify or expand the search:
- PubMed search for NCT03236207
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cow Milk Allergy
Currently open trials in the same condition.
- NCT06380673 — Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy · NA · recruiting
- NCT05785299 — Clinical Versus Home Introduction of Milk in Children with Non-IgE-mediated Cow's Milk Allergy · NA · recruiting
- NCT04249973 — Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in Children · active not recruiting
Other Société des Produits Nestlé (SPN) trials
Trials by the same sponsor.
- NCT07312201 — Oral Nutritional Supplementation in Children With Growth Concerns · NA · not yet recruiting
- NCT07378111 — Vegetarian Tube Feed Study · NA · not yet recruiting
- NCT07439718 — The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome · NA · recruiting
- NCT07341464 — Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends · NA · recruiting
- NCT07127198 — Tolerance and Appetite Reduction of a Nutritional Solution With Intragastric Gelation Properties · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03236207 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Société des Produits Nestlé (SPN)
- Last refreshed: 30 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03236207.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing